drugset / Trial / NCT02271464

Maintenance Bevacizumab Only or Bevacizumab Plus Metronomic Chemotherapy in Advanced Colorectal Cancer

NCT02271464

Phase 2 Completed 232 enrolled Azienda Ospedaliero, Universitaria Pisana
RandomizedParallel-groupOpen-labelTreatment

Summary

This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients. The main objective of this study is to preliminarily evaluate the potential effects of the combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.

Timeline

Start
2012-03
Primary completion
2017-03
Completion
2017-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 500 mg Oral
Subject Cyclophosphamide Other / unclassified 50 mg Oral
Background Irinotecan Small molecule 165 mg/m2 Intravenous
Background Levoleucovorin Unknown 200 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 3200 mg/m2 Intravenous

Indications